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FDA 510(k)

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System

K-Number: K203129 · 2021-01-12

ApplicantPrecision Spine, Inc.
Decision Date2021-01-12
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2021-01-12 under approval number K203129. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System?

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is a medical device that received FDA 510(k) clearance on 2021-01-12. It is manufactured by Precision Spine, Inc.. The 510(k) number is K203129.

When was NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System approved by the FDA?

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System received FDA 510(k) clearance on 2021-01-12, under approval number K203129.

What company makes NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System?

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is manufactured by Precision Spine, Inc..

What is the FDA product code for NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System?

The FDA product code for NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is OVE.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Precision Spine, Inc.

K161809ShurFit CpTi-HA ACIF Interbody Fusion System K162211AccuFit Lateral Plate System K162300Reform® POCT System K160568Precision Spine Interspinous Plate System K173130Reform® Midline Cortical Screw System K171657ShurFit 2C Lumbar Interbody Fusion System

View all 17 devices →

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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